The present invention relates generally to a closure that may be applied to a vial, bottle, or other container, which can be described as a closure and container assembly, or closure and container system. The closure and container assembly stores and dispenses materials, particularly pharmaceuticals.
The closure is selectively manipulable between a child resistant configuration and a non-child resistant configuration. In its child resistant configuration, the closure provides an obstacle to children being able to remove the closure from the container. However, in its non-child resistant configuration, the closure allows for its ready removal from the container.
There are many types of child resistant closure systems described in the art. An example of a particular type of child resistant closure system is proposed in U.S. Pat. No. 5,449,078, which relates to a combination of a container and safety cap in which the cap continuously remains in a child resistant configuration. While many child resistant caps effectively provide protection against the danger of small children being able to remove potentially harmful contents, e.g. pills, from vials or other containers, they also provide a problem for a considerable portion of the adult population that require medication but lack the manual dexterity or strength to remove the child resistant cap. This is of a particular concern to the elderly population or people suffering from arthritis and other disabling diseases.
The most popular type of child-resistant closure is known in the art as a continuous threaded, torque actuated child resistant closure. These caps involve the use of two parts, one of which rests above the other in an axial configuration and which requires both a rotational and downward action to engage for removal. These are used in literally thousands of various applications and packaging configurations due to the universally understood push and turn mechanisms and the ease of use and adaptation in a wide variety of automated filing lines and processes. Most of these prior art torque actuated child resistant closures are continuously in a child resistant mode and, therefore, can pose a problem to the segment of the population needing the pharmaceuticals contained therein, but lacking the manual dexterity or strength to open the axially, torque actuated closures. Additionally, most of the torque actuated child resistant closures are composed of two separate pieces.
A typical example of this push and turn, torque actuated closure in the art includes two or more cap elements arranged such that an inner cap is nestled within an outer cap element wherein the inner and outer cap are equipped with an engaging device. The engaging device of the inner and outer caps can allow relative independent rotation or couple the inner and outer caps in order to remove the cap system from the container. Examples include those proposed in U.S. Pat. Nos. 4,520,938 and 7,000,789. The Inventors herein have observed that when the outer cap is made of resilient materials such as plastic, a risk exists in these types of patents that children could separate one cap from the other (“Shelling”) thereby disabling the child resistant mode of operation. Once shelled, there is usually no other safeguard to restrict the access of the contents of the container by children.
Additionally, there have been prior art examples of reversible caps in which the cap has a child resistant side and a non-child resistant side such that a user of the cap and container system flips the cap 180 degrees to switch from the child resistant and non child resistant positions, such as seen in U.S. Pat. No. 6,926,161. While an effective solution to the problem these caps are susceptible to potential contamination by the switching between the child resistant and non child resistant configurations. For example, when one side of the cap (i.e. the NCR side) has been exposed for a period of time, reversal of the cap into the opposite mode positions the previously exposed side (in this example the NCR side) and any contaminates on that side to the pharmaceuticals contained within the vial.
Another example of a prior attempt at a closure system is disclosed in U.S. Pat. No. 5,579,934. This Patent proposes a container closure that is convertible between a configuration that resists opening by children and a configuration which may be easily opened without special manipulation of the closure. Specifically, the closure is manipulated into a non child resistant mode by “pressing down” on a central portion of the top surface of the closure. The action of pressing down moves the inner cap of the closure system relative to the outer cap and engages members inside the closure that restrict relative rotation between the inner and outer caps. This type of cap can also then be an effective solution to previous prior art problems. However, these caps are composed of two separately manufactured pieces that are then assembled. This increases the both the manufacturing cost and assembly time for the caps. Additionally, heretofore these caps have lacked the capability to properly include a warning to the consumer once this closure has been converted to its non child resistant configuration. This warning, or message, is normally required by the Consumer Product Safety Commission (“CPSC”) to alert users that the closure has been converted into the non child resistant configuration.
Other reversible or convertible child resistant closures have been posed to address various problems. However, making the closure easier to convert into the non child resistant configuration increases the risk that these closures will inadvertently be converted to the non child resistant configurations. This obviously creates a health hazard. Similarly, there is an increased risk that the automated filling machines will inadvertently convert the closures to the non child resistant configurations when applying the closure to the container. Additionally various reversible and convertible child resistant designs that do include the CPSC consumer warning have projections that limit the use of those designs in automated dispensing equipment due to the projections on the outer surfaces or the overall configurations of those closures and/or caps.
In light of the foregoing there is need for a closure and container system that has a child resistant mode that effectively restricts access to the pharmaceuticals inside the container by children and allows access once a minimal torque threshold has been overcome. The closure and container system preferably has a non child resistant mode which may be opened without special manipulation. Preferably the closure is resistant to inadvertent conversion from its child resistant mode to its non child resistant mode, is composed of a one piece construction, and can be used in automated dismissing machines. This need closure and closure and container system is lacking in the art.